Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
NCT04128852 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-02-13
Summary
This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion (extreme lateral interbody fusion (XLIF). MagnetOs Putty will be used according to the instructions for use.
Conditions
- Degenerative Disc Disease
Interventions
- DEVICE
-
MagnetOs Putty
MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958).
Sponsors & Collaborators
-
Factory CRO
collaborator INDUSTRY -
The London Clinic
collaborator OTHER -
Kuros BioSciences B.V.
collaborator INDUSTRY -
Kuros Biosurgery AG
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-11
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
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